Director, GRA CMC Small Molecules
2 weeks ago
Join Takeda as a Director, GRA CMC Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff. Demonstrate high level of leadership and expert understanding of global RA CMC regulations and guidelines by applying interpersonal skills and expert RA CMC knowledge to address and overcome challenges that arise during development and commercialization.
You will also communicate and negotiate with international Health Authorities as necessary, directly and indirectly. Provide regulatory CMC expertise for new business development/due diligence activities. Proactively recognizes and contributes to enhancing business processes.
As part of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC.
How you will contribute:
- Independently plan, execute and manage regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities.
- Member of global cross-functional teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance within the organization.
- Lead team members that defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirements.
- Lead and/or contribute to business process development and enhancement
- Evaluate new business development opportunities or participate on due diligence teams.
- Develop and maintain constructive relations with key internal and external colleagues, e.g. cross functional colleagues within Takeda, Alliance Partners, and Health Authority representatives.
- Responsible for ensuring that project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
- Exercise good judgement in elevating and communicating actual or potential issues to line management.
- Communicates and negotiates with international Health Authorities as necessary, directly and indirectly.
- Represent Takeda RA CMC in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters.
- Interact directly with international Health Authorities, as required.
- Proven ability to liaise with Regulatory Agencies, having served as lead in successful Agency Interactions related to CMC submissions and product development meetings; international experience preferred.
- Manage and develops staff, if required, including staff professional development and project oversight accountability.
- Evaluate change proposals for regulatory impact and filing requirements.
-
Director, GRA CMC Small Molecules
1 week ago
Cambridge, United States Takeda Full timeJoin Takeda as a Director, GRA CMC Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff. Demonstrate high...
-
Director, GRA CMC Small Molecules
1 week ago
cambridge, United States Takeda Full timeJoin Takeda as a Director, GRA CMC Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff. Demonstrate high...
-
Director/Senior Director CMC
4 weeks ago
Cambridge, United States tapwage Full timeMOMA Therapeutics is looking for an experienced CMC Director/Senior Director. Imagine joining a company where you…. - Will be part of an experienced and resilient team that is collectively unstoppable, trusts one another, and selflessly collaborates - Will work with incredible humans who are committed to the discovery of transformative medicines for...
-
Director/Senior Director CMC
3 weeks ago
Cambridge, Massachusetts, United States tapwage Full timeMOMA Therapeutics is looking for an experienced CMC Director/Senior Director.Imagine joining a company where you.... Will be part of an experienced and resilient team that is collectively unstoppable, trusts one another, and selflessly collaborates Will work with incredible humans who are committed to the discovery of transformative medicines for patients...
-
RegCMC Small Molecules Team Lead
1 week ago
Cambridge, United States Biogen Full timeJob DescriptionJob DescriptionJob DescriptionAbout this roleAs Regulatory CMC Small Molecules Team Lead you are responsible for the line management of direct reports, with responsibilities for the small molecule portfolio. The Regulatory CMC Team Lead with the Regulatory CMC Global Regulatory Lead (RegCMC GRL), where applicable, assigns activities to the...
-
Regulatory Affairs Manager
6 days ago
Cambridge, Massachusetts, United States Biogen Full timeJob SummaryWe are seeking a highly experienced Regulatory CMC Team Lead to lead our small molecules portfolio. As a key member of our Regulatory CMC team, you will be responsible for defining regulatory CMC strategy, planning, and preparation of global CMC regulatory submissions to achieve timely approvals of clinical trial applications, initial marketing...
-
Associate Director, Regulatory CMC
3 months ago
Cambridge, Massachusetts, United States Intellia Therapeutics Full timeWhy Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...
-
Associate Director, Regulatory CMC
3 months ago
Cambridge, United States Intellia Therapeutics Full timeWhy Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...
-
Cambridge, Massachusetts, United States Takeda Full timePosition OverviewAt Takeda, we are committed to pioneering advancements in research and development that lead to transformative therapies for patients. Our focus on four key therapeutic areas, along with targeted investments, allows us to redefine the possibilities in delivering life-altering treatments globally.As the Senior Director of Regulatory Affairs...
-
Cambridge, Massachusetts, United States Novartis Group Companies Full timeJob SummaryWe are seeking a highly driven professional with a strong cancer biology background and track record of successfully leading small molecule drug discovery projects from early to development candidate stage.Key Responsibilities:Lead and mentor a team of scientists in oncology drug discovery and early development.Develop and execute strategies to...
-
Director of Quality Assurance Operations
2 weeks ago
Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a pioneering biopharmaceutical organization focused on developing groundbreaking therapies to combat severe, progressive ocular diseases that can result in vision loss. Our primary investigational compound, gildeuretinol (ALK-001), is an oral medication under development for treating Stargardt...
-
Director of Quality Assurance Operations
1 week ago
Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a biopharmaceutical organization focused on developing innovative therapies for serious eye diseases that can result in vision loss. Our primary investigational compound, gildeuretinol (ALK-001), is an oral medication aimed at treating Stargardt disease (STGD) and Geographic Atrophy (GA) linked to...
-
Director of Quality Assurance Operations
1 week ago
Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a pioneering biopharmaceutical organization focused on developing innovative therapies for serious eye diseases that can lead to vision loss. Our primary investigational compound, gildeuretinol (ALK-001), is an oral medication being explored for the treatment of Stargardt disease (STGD) and...
-
Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical organization focused on developing groundbreaking therapies for serious, progressive ocular diseases that can result in vision loss. Our primary investigational compound, gildeuretinol (ALK-001), is an oral medication under development for treating Stargardt disease...
-
Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a pioneering biopharmaceutical firm focused on developing groundbreaking therapies for serious eye diseases that can lead to vision loss. Our flagship compound, gildeuretinol (ALK-001), is an oral investigational medication aimed at treating Stargardt disease (STGD) and Geographic Atrophy (GA)...
-
Cambridge, Massachusetts, United States Novartis Group Companies Full timeJob DescriptionJob Summary:We are seeking a highly driven professional with a strong cancer biology background and track record of successfully leading small molecule drug discovery projects from early to development candidate stage.About the Role:The individual will play a key role in advancing drug discovery programs as well as leading initiatives towards...
-
Cambridge, Massachusetts, United States Novartis Full timeAbout the RoleWe are seeking a highly driven professional with a strong cancer biology background and track record of successfully leading small molecule drug discovery projects from early to development candidate stage. The individual will play a key role in advancing drug discovery programs as well as leading initiatives towards the inception and...
-
Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical organization dedicated to developing groundbreaking therapies aimed at treating severe, progressive ocular diseases that can result in vision loss. Our primary investigational compound, gildeuretinol (ALK-001), is an oral medication currently being explored for its...
-
Associate Director, Quality Assurance Operations
1 month ago
Cambridge, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company developing transformative therapeutics to address serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease (STGD) and Geographic...
-
Associate Director, Quality Assurance Operations
1 month ago
Cambridge, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company developing transformative therapeutics to address serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease (STGD) and Geographic...
